Clinical Quality Assurance Specialist H/F - 69

Excelya is an independent partner that serves Biotech, Pharma, and Medical Device organizations with a comprehensive range of full-service CRO, FSP, and Resourcing solutions guided by our values Energy, Care and Audacity.

Founded in 2014 and headquartered in Paris, France, Excelya has a global team of 900+ experts who understand the critical needs of clients to provide bespoke and robust trial solutions across a broad spectrum of therapeutic areas.

We take a one-team approach to work: our shared success is the result of collaboration at every stage of a project, from regulatory affairs and clinical operations to quality assurance and strategic development.

Excelya is committed to helping our clients deliver life-changing therapies collaboratively, so we can transform tomorrow together.AbouttheJob

JoinExcelya,whereAudacity,Care,andEnergydefinewhoweareandhowwework.Webelieveincreatingboldsolutionsandfosteringaninclusiveenvironmentwherecollaborationandindividualgrowthgohandinhand.

Thisroleisanexcitingopportunitytocontributetoadynamic,ambitiousteam.Youwillplayacriticalpartindrivinginnovatio andmakinganimpactintheclinicalresearchspace,whileenjoyingastimulatingprofessionalenvironmentthatencouragespersonalandintellectualgrowth.

Activities

- Review QA documentation related to clinical trials
- Ensure completeness of clinical and quality records
- Assess and track complaints from CROs and sites
- Review audit reports and monitor follow-ups
- Manage SCARs (Supplier Corrective Action Requests)
- Support CAPA implementation and closure
- Follow up on non-conformities (NCFOs)
- Oversee QA documentation for clinical development
- Support GCP inspection readiness (EMA, ANSM, FDA)
- Ensure compliance with GCP and internal SOPs
- Perform QA gap analyses and suggest remediations
- Follow up on audit findings and CAPAs
- Coordinate with internal stakeholders (ClinOps, RA, PV)
- Contribute to QA process improvements and mock inspections